About the job
Core
Lead CMC (Chemistry, Manufacturing, and Controls) development for Radiopharmaceutical Therapy (RPT), managing precursor and finished drug development, RI supply strategy, GMP manufacturing, and IND documentation.
Role type
Senior CMC Lead (Radiopharmaceuticals)
Builds
GMP-ready processes for small molecule and peptide-based candidates, radiopharmaceutical formulations, and regulatory submission packages.
Domain
Biopharmaceuticals / Radiopharmaceuticals / Nuclear Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing, CDMO management, IND Module 3 writing, process development for small molecules/peptides, risk management, cross-functional collaboration
Preferred skills
Radiolabeling, Radiochemistry, Sterile Injectable development, Tech Transfer, Process Validation, FDA/EMA regulatory experience
Technologies
GMP, CDMO, IND, Small molecule, Peptide
Responsibilities
Develop GMP manufacturing processes for small molecule and peptide candidates; Design radiopharmaceutical formulations and build CMC documentation; Manage GMP manufacturing plans and schedules; Select and manage domestic and international CDMOs; Prepare and review CMC data for global regulatory submissions; Resolve manufacturing, quality, and supply issues with QA, RA, and clinical teams.
Seniority
Senior, hands-on IC